Seroconversion Among Staff at a Large Acute Care Hospital in Denmark During the COVID-19 Pandemic

The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital. This will enable the identification of those who are protected and non-infectious for SARS-CoV2 and those who are seronegative and therefore potentially susceptible and infectious on patient contact. Prospective testing will provide data on the acquisition of SARS-CoV2 infections among HCWs and associated risk factors for transmission during a pandemic at an acute care hospital facility in the capital region of Denmark.

Hypothesis: Serial seroconversion measurements in hospital employees improve the organization of the clinical treatment and care during the COVID-19 pandemic at Nordsjællands Hospital and Nykøbing Falster County Hospital.

Study Overview

• Status: Recruiting
• Conditions: Covid-19; Health Personnel; Personnel, Hospital
• Intervention / Treatment: Other: Serial seroconversion measurements in hospital employees during the COVID-19 pandemic

Detailed Description

The study is a prospective cohort study. Weekly (in the first phase) and bi-weekly (in the second phase) serum samples will be drawn and shipped bi-weekly to laboratory collaborators in United Kingdom for antibody analyses during the course of the local epidemic, expected to last 10-12 weeks or more. After the cease of the epidemic serum will be drawn in 3-monthly intervals in a smaller group of seroconverted volunteers to follow the long-lasting immunity of SARS-CoV-2 infection up to 5 years post-pandemic.

Nurses, medical doctors, biomedical laboratory scientists, social health care assistants, and few healthcare administrators (as controls) will be invited for enrolment. In hospitals, all departments with staff that are in physical contact with patients during the pandemic will be invited to participate in the study.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Fischer; Phone Number: +45 2440 1718; Email: thea.koelsen.fischer@regionh.dk

Study Locations

• Denmark
  • Capital Region
    • Hillerød, Capital Region, Denmark, 3400
      • Recruiting
      • Nordsjællands Hospital
      • Contact: Thea K Fischer; Phone Number: +45 2440 1718; Email: thea.koelsen.fischer@regionh.dk
  • Southern Region
    • Nykøbing Falster, Southern Region, Denmark, 4800
      • Recruiting
      • Nykøbing Falster County Hospital
      • Contact: Gry St-Martin, md; Phone Number: +45 20537137; Email: grys@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Health care workers at two Danish hospitals

Description

Inclusion Criteria: hospital employee

-

Exclusion Criteria: none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Serial seroconversion measurements in hospital employees; Serial seroconversion measurements in hospital employees during the COVID-19 pandemic	Other: Serial seroconversion measurements in hospital employees during the COVID-19 pandemic; The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serology testing for specific COVID-19	IgM and IgG (Covid-19 antibodies)	From baseline to follow up at four years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 infection	Swab, SARS-CoV-2	From baseline to follow up at three months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Co-variates	Age, gender, employment details, smoking, chronic diseases	At baseline

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Collaborators: University of Oxford; Nykøbing Falster County Hospital
• Investigators: Principal Investigator: Thea K Fischer, professor, Nordsjællands Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 27, 2020
• Primary Completion (ANTICIPATED): August 1, 2025
• Study Completion (ANTICIPATED): August 1, 2025

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (ACTUAL): June 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: seroconversion; healthcare workers; health care workers; hcw
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Journal-nr.: H-20022312

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No